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Effects Magnesium Sulfate and Labetalol Infusion on Peripheral Perfusion and Pain in Nasal Surgeries

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ClinicalTrials.gov Identifier: NCT04688203
Recruitment Status : Completed
First Posted : December 29, 2020
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
Alshaimaa Abdel Fattah Kamel, Zagazig University

Study Description
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Brief Summary:

One of main risk of controlled hypotension during nasal surgeries is impaired perfusion. Peripheral perfusion of non-vital organs usually impaired earlier than vital organs. So, evaluation of perfusion of non-vital organ is considered to be adequate measure of patient safety during surgery.

Many hypotensive agents such as dexmedetomidine, B blockers, magnesium sulfate and nitroglycerine had been used but we are in need to investigate its effects on peripheral perfusion.

Postoperative pain related to nasal surgeries due to surgical trauma itself which induces the release of inflammatory mediators from neuronal and immune cells resulting in peripheral and central sensitization significantly affects recovery of patients. Magnesium sulfate and labetalol have analgesic actions besides their hypotensive effects but with different mechanisms.


Condition or disease Intervention/treatment Phase
Peripheral Perfusion Postoperative Pain Drug: Magnesium Sulfate Injection Drug: Labetalol Injectable Solution Phase 1 Phase 2

Detailed Description:

To compare between the effects of magnesium sulfate and labetalol infusion during induced hypotension on peripheral perfusion and postoperative pain in nasal surgeries

OBJECTIVES:

To measure peripheral perfusion index (PPI) as an indicator for peripheral perfusion To calculate the total postoperative rescue analgesic requirements.

Double -blind randomized comparative Clinical Study. All Patients will be randomly allocated into two equal groups (group M and Group L).

Using computer generated randomization table, each group will be 25 patients.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Magnesium Sulfate and Labetalol Infusion Used for Induced Hypotension on Peripheral Perfusion and Postoperative Pain in Nasal Surgeries
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Magnesium sulfate infudsion
patients will receive IV bolus dose of 40mg/kg magnesium sulfate in 100 ml saline solution over ten minutes then continuous infusion of 10-15mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.
 Drug: Magnesium Sulfate Injection
will receive IV bolus dose of 40mg/kg magnesium sulfate in 100 ml saline solution over ten minutes then continuous infusion of 10-15mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.
Other Name: magnesium sulfate
Active Comparator: Labetalol infusion
will receive IV bolus does of labetalol 0.25 mg/kg over ten minutes then continuous infusion of 0.5-1mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.
 Drug: Labetalol Injectable Solution
will receive IV bolus does of labetalol 0.25 mg/kg over ten minutes then continuous infusion of 0.5-1mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.
Other Name: labetalol


Outcome Measures
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Primary Outcome Measures :
  1. Peripheral perfusion index [ Time Frame: Changes from baseline Peripheral perfusion index at 2 hours. ]
    Peripheral perfusion index by pulse oximertry will be measured at basal, 3minutes after induction, every 10 minutes till end of surgery. It will be calculated by dividing the pulsatile signal to nonpulsatile. The normal range is (0.02% -20%)


Secondary Outcome Measures :
  1. Mean arterial blood pressure [ Time Frame: basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery ]
    Mean arterial blood pressure will be recorded at basal, 3 minutes after intubation, and after skin incision then every 10 min till the end of surgery.

  2. Heart rate [ Time Frame: basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery ]
    Heart rate will be recorded at basal, 3 minutes after intubation, and after skin incision then every 10 min till the end of surgery.

  3. postoperative Pain intensity [ Time Frame: at 30 minutes, 1 hour, 2hours, 4hours, 6hours, 12hours, and 24hours postoperative. ]
    Postoperative Pain will be assessed using Numerical rating Scale (NRS) . A commonly used scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient will be instructed to make a mark along the line to represent the intensity of pain currently being experienced. NRS score 4 or more =pain. Paracetamol 1gm IV will be given every 6 hours as a protocol for pain management will be started at the end of surgery, and IV pethidine 1mg/kg (rescue analgesic) will be given if NRS >4.

  4. time to first call for pethidine (rescue analgesic) [ Time Frame: up to 24hour postoperative ]
    Time from the stoppage of infusion solution to first call for pethidine (rescue analgesic) will be recorded.

  5. Total pethidine requirements [ Time Frame: up to 24hour postoperative ]
    Total pethidine requirements

  6. Serum lactate level [ Time Frame: basal and at one hour after extubation ]
    Serum lactate will be recorded basal and at one hour after extubation. The normal serum lactate ranges from 4.5 to 19.8 mg/dL


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent from the patient.
  • Age: 21-45 years old.
  • Sex: both sex (males or females).
  • Physical status: ASA 1& II.
  • BMI = (20-30 kg/m2).
  • Type of operations: elective nasal surgeries such as septoplasty, endoscopic sinus surgery and polypectomy.
  • Duration of surgery ≤ two hours.

Exclusion Criteria:

  • Altered mental state
  • Patients on beta blocker or with known history of allergy to study drugs.
  • Advanced hepatic, renal, cardiovascular or respiratory diseases.
  • Diabetic patients.
  • Patients receiving anticoagulants or on pain killers.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688203


Locations
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Egypt
Alshaimaa Abdel Fattah Kamel
Zagazig, Egypt, 002055
Sponsors and Collaborators
Zagazig University
Investigators
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Principal Investigator: Alshaimaa Kamel, M.D Faculty of Human medicine, Zagazig university
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alshaimaa Abdel Fattah Kamel, lecturer of Anesthesia ,and surgical intensive care, Zagazig University
ClinicalTrials.gov Identifier: NCT04688203    
Other Study ID Numbers: 6601
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Magnesium Sulfate
Labetalol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
 Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists